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Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients

Information source: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus; Microalbuminuria

Intervention: aspirin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hospital de Clinicas de Porto Alegre

Official(s) and/or principal investigator(s):
Eduardo G Camargo, Study Director, Affiliation: Programa de Pós-graduação em Ciências Médicas: Endocrinologia

Overall contact:
Sandra P Silveiro, Phone: 55 51 33325188, Email: sandrasilveiro@terra.com.br

Summary

Research design: randomized, double-blind, placebo-controlled crossover study to evaluate the putative interference of low-dose aspirin (for 8 weeks) on enalapril antiproteinuric properties in microalbuminuric type 2 diabetes mellitus patients

Clinical Details

Official title: Aspirin and the Antiproteinuric Effect of Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients: a Randomized, Double-Blind, Placebo-Controlled Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

urinary albumin excretion

glomerular filtration rate

Detailed description: Research design: randomized, double-blind, placebo-controlled crossover study Patients: Microalbuminuric (urinary albumin excretion [UAE]30-300 mg/d)type 2 diabetes mellitus patients without ischemic heart disease or peptic ulcer Aim: To evaluate the putative interference of low-dose aspirin (300 mg/d)for 8 weeks)on enalapril antiproteinuric properties in microalbuminuric type 2 diabetes mellitus patients Study protocol: Crossover randomization to 8 weeks of enalapril 10 mg/d plus aspirin (300 mg/d) or plus placebo, and a 6-week washout period. Measurement of UAE (immunoturbidimetry) and glomerular filtration rate (51Cr-EDTA), blood pressure and metabolic control at baseline and at the end of each period. Statistical analyses: Bland&Altman analyses for crossover trials.

Eligibility

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- type 2 diabetes mellitus microalbuminuria

Exclusion Criteria:

- ischemic heart disease peptic disease

Locations and Contacts

Sandra P Silveiro, Phone: 55 51 33325188, Email: sandrasilveiro@terra.com.br

Hospital de Clínicas de Porto Aelgre, Porto Alegre, RS 900035900, Brazil; Recruiting
Sandra P Silveiro, MD, Phone: 55 51 33325188, Email: sandrasilveiro@terra.com.br
Sandra P Silveiro, MD, Principal Investigator
Eduardo G Camargo, MD, Sub-Investigator
Additional Information

Starting date: March 2003
Last updated: January 26, 2007

Page last updated: August 23, 2015

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